Prostate SABR With Intra-Prostatic SABR Boost

Prostate Cancer Clinical Trial

Official title:

Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212715
• Other study ID #: E-19-4346
• Status: Recruiting
• Phase: Phase 2
• Start date: December 26, 2019
• Est. completion date: December 2026

Study information

• Verified date: December 2019
• Source: King Saud University
• Contact: Yasir Alayed, MD
• Phone: +966114671546
• Email: yalayed[@]ksu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed prostate adenocarcinoma

• High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL

• Willing to give informed consent to participate in this clinical trial

Exclusion Criteria:

• Prior pelvic radiotherapy

• Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease

• Contraindication to prostate MRI

• No evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.

• Definitive extrapelvic nodal or distant metastatic disease on staging investigations.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Pelvic SABR with intra-prostatic SABR
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule

Locations

Country	Name	City	State
Saudi Arabia	King Saud University Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Toxicity	To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria	3 month after accrual is completed